(48 days)
Not Found
No
The document describes a medical monitor and calibration software, with no mention of AI or ML capabilities for image analysis or processing.
No
The device is an LCD monitor system used for displaying medical images for review and analysis, not for directly treating a condition or disease.
No.
The device is an LCD monitor system intended for displaying medical images for review and analysis, not for performing diagnostic analysis itself. Its purpose is to present information, not to interpret it diagnostically.
No
The device description explicitly states "CW120N LCD Monitor System" and "CW120N LCD Monitor," indicating a hardware component (the monitor) is part of the device. While it includes calibration software, the core device is a physical display.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Definition of IVD: In vitro diagnostics are tests performed on samples such as blood, urine, or tissue that have been taken from the human body to detect diseases or other conditions. They are used to diagnose, monitor, or screen for diseases.
- Device Function: The CW120N LCD Monitor System is a display device. Its purpose is to show digital medical images for review and analysis. It does not perform any tests on biological samples.
- Intended Use: The intended use is to display medical images for trained medical practitioners to review and analyze. This is a crucial step in the diagnostic process, but the monitor itself is not performing the diagnostic test.
- Lack of IVD Characteristics: The description does not mention any reagents, assays, or procedures for analyzing biological samples, which are hallmarks of IVD devices.
Therefore, the CW120N LCD Monitor System falls under the category of a medical device used in the diagnostic process, but it is not an in vitro diagnostic device itself.
N/A
Intended Use / Indications for Use
CW120N LCD Monitor System is intended to be used in displaying digital medical images for review and analysis by trained medical practitioners. It is specifically designed for digital mammography applications and digital breast tomosynthesis applications.
Product codes
PGY
Device Description
CW120N LCD Monitor is intended to provide high resolution color and grayscale medical imaging for PACS and Radiology system. This Medical Monitor is intended to be used by trained medical practitioners for displaying, reviewing, and analysis of medical images.
EzCal ver.2 is a software solution which enables the user to modify display output to meet DICOM Part 14 GSDF and other key industry standards.
CW120N is being provided with the calibration software EzCal v.2 (developed by Qubyx Inc.) when requested by the customer.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
digital medical images for review and analysis
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
trained medical practitioners
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
The bench tests below were performed on the CW120N following the instructions in 'Display Devices for Diagnostic Radiology – Guidance for Industry and Food and Drug Administration Staff, issued on October 2, 2017.
· Test Item
Pixel Defects, Artifacts, Luminance, Reflection, Luminance Uniformity, Resolution, Noise, Veiling Glare, Color Uniformity, Luminance Response, Luminance at 30 degrees and 45 degrees in diagonal, horizontal, and vertical directions, Temporal Performance Test, Color Tracking, Gray Tracking, MTF
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 892.2050 Medical image management and processing system.
(a)
Identification. A medical image management and processing system is a device that provides one or more capabilities relating to the review and digital processing of medical images for the purposes of interpretation by a trained practitioner of disease detection, diagnosis, or patient management. The software components may provide advanced or complex image processing functions for image manipulation, enhancement, or quantification that are intended for use in the interpretation and analysis of medical images. Advanced image manipulation functions may include image segmentation, multimodality image registration, or 3D visualization. Complex quantitative functions may include semi-automated measurements or time-series measurements.(b)
Classification. Class II (special controls; voluntary standards—Digital Imaging and Communications in Medicine (DICOM) Std., Joint Photographic Experts Group (JPEG) Std., Society of Motion Picture and Television Engineers (SMPTE) Test Pattern).
0
April 8, 2021
Image /page/0/Picture/1 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health and Human Services logo on the left and the FDA text logo on the right. The FDA text logo is in blue and includes the letters "FDA" in a square, followed by the words "U.S. FOOD & DRUG" on one line and "ADMINISTRATION" on the next line.
Wide Corporation % Mr. Yeojin Yun RA Manager 15F, The First Tower III, 602, Dongtangiheung-Ro Hwaseong-Si, Gyeonggi-Do 18469 REPUBLIC OF KOREA
Re: K210491
Trade/Device Name: CW120N Regulation Number: 21 CFR 892.2050 Regulation Name: Picture archiving and communications system Regulatory Class: Class II Product Code: PGY Dated: January 27, 2021 Received: February 19, 2021
Dear Mr. Yun:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR 803) for
1
devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely.
Michael D. O'Hara
For
Thalia T. Mills, Ph.D. Director Division of Radiological Health OHT7: Office of In Vitro Diagnostics and Radiological Health Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known) K210491
Device Name CW120N
Indications for Use (Describe)
CW120N LCD Monitor System is intended to be used in displaying digital medical images for review and analysis by trained medical practitioners. It is specifically designed for digital mammography applications and digital breast tomosynthesis applications.
| Type of Use (Select one or both, as applicable) | |
|---|---|
| ☑ Prescription Use (Part 21 CFR 801 Subpart D) | |
| ☐ Over-The-Counter Use (21 CFR 801 Subpart C) |
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510(k) Summary
[As required by 21 CFR 807.92]
This 510(k) summary of safety and effectiveness information is prepared in accordance with 21 CFR 807.92
1. Date Prepared [21 CFR 807.92(a) (1)]
01/27/2021
2. Submitter's Information [21 CFR 807.92(a) (1)]
| Name of Sponsor: | WIDE Corporation. |
|---|---|
| Address: | 15F, The First Tower III, 602, Dongtangiheung-Ro, |
| Hwaseong-Si, Gyeonggi-Do 18469, Republic of Korea | |
| Contact Name: | YeoJin Yun |
| Telephone #: | +82-31-218-1675 |
| Fax #: | +82-31-376-9600 |
| Email: | yyjin@widecorp.com |
| Registration Number: | 3004082357 |
| Name of Manufacturer: | Same as Sponsor |
3. Trade Name, Common Name, Classification [21 CFR 807.92(a) (2)]
| Model Name: | CW120N |
|---|---|
| Common Name: | TFT LCD Medical Monitor System |
| Classification Name: | Picture archiving and communications system |
| Regulation Number: | 21 CFR 892.2050 |
| Product Code: | PGY |
| Device Class: | 2 |
| Review Panel: | Radiology |
4. Identification of Predicate Device(s) [21 CFR 807.92(a) (3)]
| 510(k) Number: K200485 |
|---|
| Applicant: EIZO CORPORATION |
| Model Name: RadiForce RX1270, RadiForce RX1270-AR |
| Common Name: 78.4 cm (30.9 inch) class Color LCD Monitor |
| Classification Name: Picture archiving and communications system |
| Regulation Number: 21 CFR 892.2050 |
| Product Code: PGY |
| Device Class: 2 |
510(k) Summary 1/4
4
5. Description of the Device [21 CFR 807.92(a) (4)]
CW120N LCD Monitor is intended to provide high resolution color and grayscale medical imaging for PACS and Radiology system. This Medical Monitor is intended to be used by trained medical practitioners for displaying, reviewing, and analysis of medical images.
EzCal ver.2 is a software solution which enables the user to modify display output to meet DICOM Part 14 GSDF and other key industry standards.
CW120N is being provided with the calibration software EzCal v.2 (developed by Qubyx Inc.) when requested by the customer.
6. Intended Use [21 CFR 807.92(a) (5)]
CW120N LCD Monitor System is intended to be used in displaying and viewing digital medical images for review and analysis by trained medical practitioners. It is specifically designed for digital mammography applications and digital breast tomosynthesis applications.
7. Technological Characteristics [21 CFR 807.92(a) (6)]
The table below presents comparisons between the subject device (CW120N) and the predicate device (K200485):
| Attributes | Predicate Device | Subject Device | Discussion
of
Differences |
|------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------|-----------------------------------------|
| Product | RadiForce RX1270,
RadiForce RX1270-AR | CW120N | - |
| Screen
technology | TFT Color
LCD Panel (IPS) | TFT Color
LCD Panel (IPS) | - |
| Screen size | 78.4cm / 30.9" | 78.4cm / 30.9" | - |
| Resolution | 4200 x 2800
(3:2
aspect ratio) | 4200 x 2800
(3:2
aspect ratio) | - |
| Pixel pitch | 0.1554 mm x 0.1554
mm | 0.1554 mm x 0.1554
mm | - |
| Backlight type | LED | LED | - |
| Maximum luminance | 1,200 cd/m² | 1,200 cd/m² | - |
| DICOM calibrated
luminance | 500 cd/m² | 500 cd/m² | - |
| Contrast ratio(typical) | 1500 : 1 | 1500 : 1 | - |
| Response
Time(typical) | 12ms
(black-white-
black) | 14ms (gray-to-gray) | Provided by the panel
manufacturers. |
| Digital Scanning
Frequency
(H / V) | HDMI: 31 - 160 kHz /
59 - 61 Hz
(VGA Text: 69 - 71 Hz)
DisplayPort: 31 - 175
kHz / 29 -
61 Hz
(VGA Text: 69 - 71 Hz)
Frame synchronous
mode:
29.5 - 30.5 Hz, 59 - 61
Hz | DisplayPort
170.4KHz, 60Hz | Differences by
manufacturers. |
510(k) Summary 2/4
5
| Analog Scanning
Frequency
(H / V) | HDMI: 31 - 160 kHz /
59 - 61 Hz
(VGA Text: 69 - 71 Hz)
DisplayPort: 31 - 175
kHz / 29 -
61 Hz
(VGA Text: 69 - 71 Hz)
Frame synchronous
mode:
29.5 - 30.5 Hz, 59 - 61
Hz | | Differences by
manufacturers. |
|-----------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------|------------------------------------------------------------------------------------------------|
| Input video signals | DisplayPort x 2,
HDMI x 1 | DisplayPort x 1 | Differences by
manufacturers. |
| Ambient Light Sensor | Yes | Yes | - |
| Luminance calibration
tools | Integrated optical
sensor
External optical sensor
Calibration software:
RadiCS | IQ Sensor,
Calibration software:
EzCal | It is only a difference in
terms of each
manufacturer, but the
functions are similar. |
| Quality-control
procedures | RadiCS | EzCal | It is only a difference in
terms of each
manufacturer, but the
functions are similar. |
CW120N Device is substantially equivalent to the currently marketed and predicate devices in terms of design features, indications for use, and safety and effectiveness.
9. Summary of Non-Clinical Data
CW120N comply with the following international and FDA-recognized consensus standards:
| IEC 60601-1: | Medical Electrical Equipment -- Part 1: General
Requirements For Basic Safety And Essential Performance |
|----------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| IEC 60601-1-2: | Medical Electrical Equipment - Part 1-2: General
Requirements For Basic Safety And Essential Performance -
Collateral Standard: Electromagnetic Compatibility -
Requirements And Tests |
The bench tests below were performed on the CW120N following the instructions in 'Display Devices for Diagnostic Radiology – Guidance for Industry and Food and Drug Administration Staff, issued on October 2, 2017.
· Test Item
Pixel Defects, Artifacts, Luminance, Reflection, Luminance Uniformity, Resolution, Noise, Veiling Glare, Color Uniformity, Luminance Response, Luminance at 30° and 45° in diagonal, horizontal, and vertical directions, Temporal Performance Test, Color Tracking, Gray Tracking, MTF
6
10. Summary of Clinical Data
No clinical studies were considered necessary and performed.
11. Conclusion [21 CFR 807.92(b) (3)]
Subject Device is substantially equivalent to the currently marketed and predicate devices in terms of design features, fundamental scientific technology, indications for use, and safety and effectiveness.
Additionally, the safety of the subject device was validated through tests including IEC60601-1 and IEC 60601-1-2. The effectiveness of the device was validated through bench tests.
The results of these tests demonstrate that CW120N meets the acceptance criteria and is adequate for this intended use. The comparison of technological characteristics, non-clinical performance data, safety testing demonstrates that the device is as safe and effective as the predicate device and performs as well as the predicate device.